Acetaminophen is a commonly and widely-used form of pain and fever-reducing medication. The FDA is asking all makers of prescription-level acetaminophen products to limit the amount of the medication to 325 milligrams per capsule or tablet.
The FDA is also asking drug manufacturers to put a boxed warning on every prescribed acetaminophen product that highlights a potential risk for severe liver injury. The warnings are the FDR's most severe warnings for prescribed medication products and are used to focus attention on serious or life-threatening risks associated with medications. The FDA is also requiring these warning labels on every prescribed product containing acetaminophen that presents the potential for people to experience an allergic reaction.
Acetaminophen is used to provide relief from mild to moderate pain related to muscle aches, colds, fevers, headaches, backaches, toothaches, and reactions to vaccinations. The drug can also assist in relieving pain due to osteoarthritis. Acetaminophen belongs to a class of drugs referred to as, 'analgesics,' or pain relievers, as well as, 'antipyretics,' or fever reducers. The drug works by changing the way a person's body senses pain and through cooling their body. Acetaminophen combined with caffeine can be used to relieve migraine headache pain as well.
Acetaminophen is used on a great many effective prescription and over-the-counter (OTC) products and remains one of the most widely-used medications in America. The drug is often used in prescribed products combined with other medications such as codeine, Hydrocodone, or oxycodone.
Acetaminophen has the potential to cause side-effects, some of which may be serious. Side-effects from acetaminophen can include a rash, hives, itching, hoarseness, swelling of a person's throat, mouth, face, eyes, lips, ankles, feet, or lower legs. The drug can also cause additional side-effects - should you experience side-effects from acetaminophen use, contact a doctor or health care professional.
Reports of Severe Liver Injury
Despite the effective use of acetaminophen by many people in the United States, the FDA continues to receive reports of people who experience severe liver injuries related to the use of medications containing acetaminophen. Dr. Sandra Kweder is the Deputy Director of the FDR's Office of New Drugs. She says the agency's most recent action is intended to make pain medications that contain acetaminophen safer for people to use. Dr. Kweder states, "Overdoses from prescription products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the U.S., many of which result in liver transplant or death." People who experience the most severe liver injuries are those who:
Dr. Kweder also said, "There is no immediate danger to patients who take these combination pain medications and they should continue to take them as directed by their health care provider. The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4,000 milligrams within a 24-hour period."
Medications Containing Acetaminophen and the Future
Medications that are over-the-counter such as Tylenol that contain acetaminophen are already required by the FDA to change the dosage labeling, making it include information about potential safety risks that include liver injury. The FDA is continuing to evaluate ways it can reduce the risk of acetaminophen-related liver injury associated with OTC medications that contain acetaminophen.
The FDR's new dosage limitation of 325 milligrams per capsule or tablet for prescribed medications does not affect aspects of prescribing acetaminophen combination medications. In other words - the number of capsules, tablets, or other dosages that a physician might prescribe, as well as the time intervals at which these medications can be administered, will remain unchanged. Additionally, the FDR's new actions are to be phased in over a period of three years, meaning that prescription pain medications that contain acetaminophen will remain available during this time frame.
Suggested Actions From the FDA
The FDA is suggesting that people do not stop taking their prescribed pain medications unless a doctor or health care professional tells them to. The FDA also has some suggestions for helping to reduce the risks of adverse effects from acetaminophen, including:
The FDA also states that you should stop taking an acetaminophen-containing medication and seeking medical assistance immediately if you:
Another suggestion the FDA has made is that people do not try to calculate the total amount of acetaminophen-containing medications they have taken each day. Instead, the person should contact a health care professional and discuss all of their medications, to include both prescribed and over-the-counter ones, they take each day - including ones containing acetaminophen.